510(k) · Cleared
ClearedRE-Entrant Chamber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sun Nuclear Corp. · KPT Calibrator, Dose, Radionuclide
Cleared on Jul 2, 2002 as substantially equivalent to K922554 (Standard Imaging, Inc., 1992) and 1 other predicate after a 238-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Jul 2, 2002
- Review
- 238 days
- Class
- Class II
- Product code
- KPT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K922554 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK922554 Standard Imaging HDR 1000 Ion ChamberStandard Imaging, Inc. · 1992
- This deviceK013689 RE-Entrant ChamberSun Nuclear Corp. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922554 | Standard Imaging HDR 1000 Ion Chamber | Standard Imaging, Inc. | 1992 | — |
| 0 (this device) | K013689 | RE-Entrant Chamber | Sun Nuclear Corp. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KPT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K922554 | Standard Imaging HDR 1000 Ion ChamberSummary page 1…90JAQ Classification Name: System, Applicator, Radionuclide, Remote-Controlled Substantial Equivalence: Standard Imaging HDR- 1000 Ion Chamber, K922554 Standard Imaging IVB 1000 Ion Chamber, KO0 1825 Contact: Jim Mixon, Quality Assurance… | 1992 |
| * | K001825 | Standard Imaging HDR 1000 Plus Ion Chamber; Standard Imaging Ivb 1000 Ion Chamber | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K922554.
How does its category compare?
All KPT devicesKPT Calibrator, Dose, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPT
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · KPT
Too few KPT 510(k)s in any year since 2007 to give a median.
Recalls per year · KPT
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPT
No MAUDE report names KPT since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 1 | 0 |
| 2011 | 0 | — | 1 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Model 1008 (&ID as marketed under CNMC) is a well-type, re-entrant ionization chamber intended for measurement of source strength of both clinical HDR and LDR brachytherapy sources and intravascular brachytherapy (1VB) sources. Both types of IVk sources can be measured; those designed to deliver a gamma dose and those designed to deliver a beta dose. The chamber must be calibrated before any measurement of a clinical source takes place. Source…
Read the full statement (133 words)
The Model 1008 (&ID as marketed under CNMC) is a well-type, re-entrant ionization chamber intended for measurement of source strength of both clinical HDR and LDR brachytherapy sources and intravascular brachytherapy (1VB) sources. Both types of IVk sources can be measured; those designed to deliver a gamma dose and those designed to deliver a beta dose. The chamber must be calibrated before any measurement of a clinical source takes place. Source strength calculation must be done with the accompanying calibration certificate from the calibration laboratory. The calibration must be performed by an accredited dosimetry calibration laboratory, with the same source type and isotope that is used clinically. The chamber constancy must be monitored after calibration with a proper Measurement'Quallty Assurance program in order to validate the chamber calibration over a period of time,
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013689 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013689: RE-Entrant Chamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013689
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026